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佐妥昔单抗联合化疗方案一线治疗CLDN18.2阳性且HER2阴性晚期胃癌的药物经济学评价
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| 篇名： | 佐妥昔单抗联合化疗方案一线治疗CLDN18.2阳性且HER2阴性晚期胃癌的药物经济学评价 |
| TITLE： | Pharmacoeconomic evaluation of zolbetuximab combined with chemotherapy as first-line treatment for CLDN18.2-positive and HER2-negative advanced gastric cancer |
| 摘要： | 目的 从我国卫生体系角度出发，评估佐妥昔单抗联合化疗方案用于紧密连接蛋白18.2（CLDN18.2）阳性且人表皮生长因子受体2（HER2）阴性晚期胃癌一线治疗的经济性。方法基于GLOW研究中CLDN18.2阳性且HER2阴性晚期胃癌患者的个体数据，对佐妥昔单抗联合化疗方案与单纯化疗方案进行比较。采用动态Markov模型进行模拟，模型周期设定为21d，研究时限为10年。采用成本-效用分析法，成本与健康产出均采用5%的年贴现率。主要评价指标包括总成本、质量调整生命年（QALY）和增量成本-效果比（ICER），意愿支付（WTP）阈值为3倍2024年我国人均国内生产总值（287247元/QALY）。采用单因素敏感性分析及概率敏感性分析验证模型的稳健性；进一步开展情境分析和阈值分析，探索佐妥昔单抗价格调整对该联合方案经济性的影响及临界价格。结果与单纯化疗方案相比，佐妥昔单抗联合化疗方案的ICER为2611943.00元/QALY。单因素敏感性分析结果显示，无进展生存状态效用值、佐妥昔单抗成本和体表面积是影响ICER最主要的3项参数。概率敏感性分析结果显示，当WTP阈值为2617450元/QALY时，该联合方案具有经济性的概率接近50%。情境分析结果显示，仅当佐妥昔单抗价格下调至基准价的10%时，该联合方案的ICER才能低于上述WTP阈值。阈值分析结果进一步表明，当佐妥昔单抗单价降至3.81元/mg时，该联合方案具有经济性的概率约为50%。结论基于我国卫生体系角度，在当前定价下佐妥昔单抗联合化疗方案作为CLDN18.2阳性且HER2阴性晚期胃癌的一线治疗方案，相较于单纯化疗方案不具备成本-效用优势。当佐妥昔单抗单价降至3.81元/mg及以下时，该联合方案才具备经济性。 |
| ABSTRACT： | OBJECTIVE To evaluate the cost-effectiveness of zolbetuximab combined with chemotherapy as first-line treatment for CLDN18.2-positive and HER2-negative advanced gastric cancer from the perspective of China’s healthcare system. METHODS Based on individual data from the GLOW clinical trial involving CLDN18.2-positive and HER2-negative patients with advanced gastric cancer， a comparison was made between the zolbetuximab combined with chemotherapy regimen and the chemotherapy alone regimen. A dynamic Markov model was employed for simulation， with a cycle length of 21 days and a time horizon of ten years. A cost-utility analysis was employed， with both costs and health outcomes discounted at an annual rate of 5%. The primary outcome measures included total cost， quality-adjusted life years （QALY） and incremental cost-effectiveness ratio （ICER）， with the willingness-to-pay （WTP） threshold set at three times China’s per capita gross domestic product in 2024 （287 247 yuan/QALY）. One-way analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Furthermore， scenario analysis and threshold analysis were conducted to explore the impact of drug price adjustments on cost-effectiveness and the threshold price. RESULTS Compared with the chemotherapy alone regimen， the ICER of zolbetuximab combined with chemotherapy was 2 611 943.00 yuan/QALY. One-way sensitivity analysis indicated that the utility value of the progression free survival， the cost of zolbetuximab and body surface area were the three most influential parameters affecting the ICER. The results of the probabilistic sensitivity analysis showed that when the WTP threshold was set at 2 617 450 yuan/QALY， the probability that the combined regimen was cost-effective approached 50%. Scenario analysis revealed that only when the price of zolbetuximab was reduced to 10% of the baseline price did the ICER of the combined regimen fall below the aforementioned WTP threshold. Threshold analysis further indicated that when the unit price of zolbetuximab dropped to 3.81 yuan/mg， the probability of the combination regimen being cost-effective was approximately 50%. CONCLUSIONS From the perspective of China’s healthcare system， zolbetuximab combined with chemotherapy regimen as first-line treatment for CLDN18.2-positive and HER2-negative advanced gastric cancer is not cost-effective compared with chemotherapy alone regimen. When the unit price of zolbetuximab drops to 3.81 yuan/mg or below， the regimen becomes cost-effective. |
| 期刊： | 2026年第37卷第07期 |
| 作者： | 黄鹰；黎苏；王艳；黄丹雪 |
| AUTHORS： | HUANG Ying，LI Su，WANG Yan，HUANG Danxue |
| 关键字： | 佐妥昔单抗；晚期胃癌；CLDN18.2阳性；HER2阴性；一线治疗；成本-效用分析；药物经济学 |
| KEYWORDS： | zolbetuximab； advanced gastric cancer； CLDN18.2 positive； HER2 negative； first-line treatment； cost-utility |
| 阅读数： | 19 次 |
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